WASHINGTON — This is the week President Joe Biden had flagged to launch a massive coronavirus booster campaign that would eventually reach every vaccinated person in the country. Instead, the booster effort is bogged down in criticism and confusion at home and abroad.
Food and Drug Administration advisers decided to recommend booster shots only for those over age 65 or at special risk — rather than Biden's public preference of everyone 16 years and older — after a month of controversy in which top FDA scientists resigned and outside medical experts complained that the White House appeared to be pressuring the agency to greenlight boosters for all.
Once again, Biden took heat for an artificial deadline, as medical experts questioned the decision to put a public timeline on the widespread availability of booster shots.
"I think it would have been one thing to say, look, logistically, operationally, the big retail pharmacy chains, departments of health, hospital system need to be prepared for giving boosters — but for it to be a communicated to the general public 'boosters are coming Sept. 20' is a very different thing," said Dr. Céline Gounder, an infectious disease expert who advised the Biden transition. "I think that is where that communication went wrong."
Biden and his top public health officials made the highly unusual move of announcing last month, before the standard FDA review process, that those 16 years and older would start getting booster shots this week. But a panel of FDA advisers rejected the plan Friday, voting that boosters should be given only to senior citizens and those at increased risk of infection.
Biden announced the plan and the timeline in a televised address, but White House officials have sought to distance him from the effort in recent days, stressing that the decision was made by his top health officials, including the acting FDA commissioner and the director of the Centers for Disease Control and Prevention.
When the administration announced it, officials said the plan was contingent on sign-off from the FDA and a group of CDC advisers who will weigh in this week. The surgeon general, Dr. Vivek Murthy, said Friday that the administration would follow the FDA and CDC recommendations.
"We have always said that this initial plan would be contingent on the FDA and the CDC's independent evaluation," he said. "We will follow that evaluation and their recommendations. We will make sure our final plan reflects it."
Still, more than a million people have already gotten third doses, which have been cleared to be given as boosters only to people with immune system disorders; numbers rose sharply after officials announced their booster plan.
White House Covid coordinator Jeffrey Zients said the administration decided to put out its own plan before the FDA to be transparent about its thinking about boosters and to give health care providers time to prepare.
While the White House has taken criticism, some public health officials have defended the approach, saying officials needed to come out quickly to prepare the public for the likelihood of boosters, especially as other countries acted and the numbers of breakthrough cases in the U.S. rose.
"I think the White House did the right thing in foreshadowing that boosters are going to be needed," said Dr. Leana Wen, an emergency physician and former Baltimore health commissioner. "What if they hadn't said anything? Even at that point, Israel, the U.K., Germany, among others, were already talking about boosters. There was a growing chorus of experts asking for what their plan would be around boosters."
Biden is expected to face pressure at the U.N. General Assembly meeting in New York this week from world leaders who have pleaded with the U.S. to do more to help the billions of people who have yet to get their first doses of a vaccine before providing people in the U.S. with third shots.
The World Health Organization has called for a "moratorium" on boosters, and other international medical groups have blasted Biden for pushing to get third doses to people in the U.S. when only 20 percent of eligible people in lower-income countries have been at least partly vaccinated, compared to around 80 percent in some of the wealthiest countries, according to the WHO.
"I will not stay silent when companies and countries that control the global supply of vaccines think the world's poor should be satisfied with leftovers," WHO Director-General Tedros Adhanom Ghebreyesus said at a news conference this month. "Because manufacturers have prioritized or been legally obliged to fulfill bilateral deals with rich countries willing to pay top dollar, low-income countries have been deprived of the tools to protect their people."
Biden, who has indicated that he will announce new U.S. efforts to help with the global supply this week, plans to ask world leaders at a virtual Covid summit Wednesday to commit to improve equitable access to vaccines, oxygen supplies, tests and protective equipment and to establish a better health financing system.
In response to the criticism, White House officials have said the U.S. is able to both give boosters and lead efforts to vaccinate the world, citing the 140 million doses it has already delivered to more than 90 countries. The U.S. plans to ship at least 200 million more doses this year.
Administration officials declined to comment on a Washington Post report Friday that the White House was in talks with Pfizer to buy millions of additional doses of its vaccine to donate overseas.
At the same time, COVAX, an international organization tasked with speeding the production and distribution of vaccines, said this month that it expects to fall short of its goal to deliver 2 billion doses to developing countries this year. Instead, the group said, it expects to have access to 1.4 billion doses this year, unless producers and higher income-countries prioritize getting vaccines to lower-income countries.
"It makes us look really bad, not that that should dictate our decision-making on this issue, but it is not a good look," said Gounder, the infectious disease expert. "I'm also just not impressed by how we have stepped up to try to get the rest of the world vaccinated. I don't think the efforts have been adequate."
CORRECTION (Sept. 19, 2021, 5:45 p.m. ET): A previous version of this article misstated when the World Health Organization's director-general criticized U.S. plans for booster shots. He made the remarks Sept. 8, not last week. It also misstated when a group of CDC advisers is scheduled to meet to discuss booster shots. The meeting is scheduled for this week, not next week.
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